Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy

A Pharmacogenetic Case-Control Study of Severe Diarrhea and Life-Threatening Neutropenia in Patients Treated With Irinotecan, 5-Fluorouracil and Leucovorin

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00048971

Enrollment

308

Registered

2003-01-27

Start date

2002-04-30

Completion date

2006-11-30

Last updated

2016-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Diarrhea, Neutropenia

Keywords

adenocarcinoma of the colon, stage III colon cancer, diarrhea, neutropenia

Brief summary

RATIONALE: Genetic testing may help predict how patients will respond to chemotherapy drugs and may help doctors plan more effective treatment with fewer side effects. PURPOSE: Genetic study to determine how genes affect the severity of diarrhea in patients with stage III colon cancer who are receiving chemotherapy.

Detailed description

OBJECTIVES: * Determine whether the presence of a 7 allele at the UGT1A1 locus is associated with either grade 3-4 diarrhea or grade 4 neutropenia in patients with stage III colon cancer after treatment with irinotecan, fluorouracil, and leucovorin calcium. * Determine whether polymorphisms in the TS enhancer and/or MTHFR gene are associated with grade 3-4 diarrhea in these patients after treatment with fluorouracil and leucovorin calcium. * Determine whether polymorphisms in UGT1A1, TS, MTHFR, CYP3A4, or CYP3A5 are associated with either grade 3-4 diarrhea or grade 4 neutropenia in these patients after treatment with irinotecan, fluorouracil, and leucovorin calcium. OUTLINE: Patients are stratified according to prior therapy (irinotecan, fluorouracil, and leucovorin calcium vs fluorouracil and leucovorin calcium) and prior toxic effects (grade 3-4 diarrhea vs grade 4 neutropenia vs grade 1 or lower diarrhea AND grade 2 or lower neutropenia). Patients undergo collection of blood specimens for polymerase chain reaction and restriction fragment length polymorphism analysis. Genotyping assays are performed to determine UGT1A1 promoter genotyping, UGT1A1 coding polymorphisms, TS promoter polymorphisms, and MTHFR polymorphisms.

Interventions

GENETICmutation analysis

GENETICpolymorphic microsatellite marker analysis

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed stage III adenocarcinoma of the colon * Enrolled on CALGB-89803 and must fall into 1 of the following categories: * Received irinotecan, fluorouracil, and leucovorin calcium and experienced at least 1 of the following: * Grade 3-4 diarrhea * Grade 4 neutropenia * Grade 1 or lower diarrhea AND grade 2 or lower neutropenia * Received fluorouracil and leucovorin calcium and experienced at least 1 of the following: * Grade 3-4 diarrhea * Grade 1 or lower diarrhea AND grade 2 or lower neutropenia PATIENT CHARACTERISTICS: Age * 18 and over

Design outcomes

Primary

Measure	Time frame
response	Up to 4 years

Countries

Canada, Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026